510(k) K000133
K000133 is an FDA 510(k) premarket notification submitted by Menicon U.S.A., Inc. for the device "MENICON Z". The FDA issued a decision of Substantially Equivalent on May 19, 2000. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Menicon U.S.A., Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2000
- Date Received
- Jan 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type
- 510(k)